STRATIFY JCV DXSELECT— 510(k) K120986
Substantially EquivalentFocus Diagnostics, Inc.
FDA 510(k) clearance K120986 for STRATIFY JCV DXSELECT, Substantially Equivalent on 2012-08-16. Applicant: Focus Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Focus Diagnostics, Inc.
- Product code
- Code OYP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3336
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code OYP
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- K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
- K102170 — SIMPLEXA FLU A/B & RSV
Recalls naming K120986
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120986.
Data sourced from openFDA. This site is unofficial and independent of the FDA.